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Specified, the Latvian journal 28.09.2005. No. 154 (3312) Cabinet of Ministers Regulations No. 725 in Riga 2005 (September 20. No 53 48. §) rules on minimum safety and labelling requirements for dietary supplements and dietary supplements registration issued under the food surveillance law article 4 of part two and 10.1 article 13, third paragraph and second paragraph of article 20 and the law on budget and financial management of the ninth article 5 part i. General questions 1. minimum safety and labelling requirements for dietary supplements that are distributed, marketed and presented as food products and delivery to the final consumer only prepackaged, as well as the registration of food supplements and related costs.
2. These provisions shall not apply to medicinal products.
3. monitoring of compliance with these provisions, and shall be carried out by the food and veterinary service.
II. Minimum safety requirements 4. Nutritional supplements are foods to supplement a normal diet. They are concentrated in nutrients (vitamins and minerals) or other substances having a nutritional or physiological effect, alone or in combination, and it distributes and distributes went — capsules, lozenges, tablets, pastilles and other ways, the powder bags, ampoules and other containers, designed for use in small and nomērīto quantities.
5. In the manufacture of food supplements allowed to use this provision in annex 1. vitamins and minerals in the connections that meet the safety requirements of food regulatory laws and regulations for dietary supplements.
III. Registration procedure 6. European Union and European economic area Member States produced and recorded for dietary supplements, which contain only 1 of these rules put Mama adequate vitamins and minerals, and is authorised to distribute in Latvia by written notification to the Latvian food centre and the food and veterinary service and sending the labelling of food supplements.
7. Food Center creates a list that contains information about this rule referred to in paragraph 6, dietary supplements, and publish it on your website on the internet.
8. Dietary supplements, which are not subject to the provisions of paragraph 6, authorised to import and distribute only after their registration in Latvia the Latvian food centre in accordance with the procedure laid down in these provisions.
9. If you submitted for the registration of food supplements, which in addition to the provisions referred to in annex I the vitamins and minerals also contains other substances and compounds, and for product documentation tation! (technical regulations manufacturer's certificate, oriģinālmarķējum, instructions, certificates or for distributing the product in Latvia submitted the sample label) contains information about product characteristics or effects suggest that the product could be drugs, the food centre of Latvia requests the opinion of the State Agency of medicines (if it is not submitted to the Latvian food centre) that the product is not to be registered as a medicine. Payment for the State Agency of medicines shall be borne by the applicant's opinion, according to the State Agency of medicines of the public paid services price list.
10. The Latvian food centre will create and maintain a register of registered food supplements. The register shall contain the following information: 10.1 the manufacturer's name, address and registration number;
10.2. the dealer's name, address and registration number;
10.3. the list of ingredients of food supplements and nutrients or substances with a nutritional or physiological effect of daily intake amount (including plants and parts thereof used names and Latvian Latin);
10.4. dietary supplements recommended daily intake;
10.5. the supply of food supplements in the form of packaging and packing unit size;
UR10.6.mar ķējum text;
10.7. instructions for use (if the applicant deems it necessary).
11. To register the rule referred to in paragraph 8. dietary supplements, the manufacturer, distributor or authorized person (hereinafter applicant) shall submit to the Latvian food centre: 11.1. submission (annex 2), which contains the following information: manufacturer and distributor of 11.1.1 (dealer) the name, address and registration number in the register of companies;
11.1.2. the product name, ingredients and their quantities in units of mass or volume per unit of presentation;
11.2. the manufacturer's approved technical documents or regulations in the product description, which outlines the characteristics of the product, a composition, specific ingredients and their quantity;
11.3. product information contained in plants, including their scientific botanical name of Latvian and Latin, each plant part used (such as flowers, root) and products (e.g., extract, powder), relevant biological active substance group names, the use of certain plant types, the permissible dose limits and warnings about possible risks of use, and special storage;
UR11.4.mar ķējum text output (sending electronically to the e-mail address: email@example.com);
11.5. usage instructions (if the applicant deems it necessary) print (send electronically to the e-mail address: firstname.lastname@example.org);
11.6. the manufacturer of the product issued a declaration of conformity, approvals or regulations established in Latvia officially recognised abroad issued product, process or service conformity assessment or certification;
7.3. The food and veterinary service food company issued a recognition or a copy of the registration certificate or the operation of the pharmaceutical regulatory laws duly received a special permit (license) the pharmaceutical activity, issued by the applicant;
11.8. the documents that you need for other food regulatory laws.
12. to products produced in third countries, registered for nutritional supplements, the Latvian Food Centre in accordance with the European Parliament and of the Council of 29 April 2004, Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, require that the applicant in addition to the provisions referred to in paragraph 11 doc ments submitted to the Latvian food centre in the European Union or European economic area Member State competent authorities to issue a conformity assessment evidence which confirms the production of food supplements (including quality control) in compliance with good manufacturing practice, or in European or international organization for standardization in the field of conformity assessment bodies accredited inspection report on the manufacturer's compliance of food to one of the following laws: 12.1. The Cabinet of Ministers on 8 April 2004 the Regulation No 269 "hygiene requirements food chain ';
12.2. European Parliament and Council of 29 April 2004, Regulation (EC) No 852/2004 on the hygiene of foodstuffs.
14. Once received this rule 11.1. the application referred to the Latvian food centre issues the invoice to the applicant a document inspection of food supplements to pay expenses.
15. Expenses related to nutritional supplements document inspection, shall be borne by the applicant amounting to: UR15.1.par one of these provisions referred to in paragraph 8 of document inspection of food supplements: 70.98 lats (excluding VAT);
previously registered UR15.2.par nutritional supplements, which will be distributed in a new form, document inspection, as well as their nutritional supplements registered after 1 May 2004, document inspection, if you changed the composition of food supplements or markings, — $35.49 (excluding VAT).
16. The Latvian food centre within 30 days after this provision 11. document referred to in paragraph 1 and the provisions referred to in paragraph 15 of the payment receipt of the Latvian food centre's general account made this provision referred to in paragraph 8 of document in food supplements and food supplements was previously registered, that will be distributed in a new form, document and take a decision.
17. If the rules referred to in paragraph 16 of the decision is positive, the Latvian food centre shall issue to the applicant a decision on dietary supplements registration and register the appropriate nutritional supplements. If the product does not meet the food regulatory regulatory requirements issued by the Latvian food Centre submitted to the jam the reasoned decision on refusal of registration.
18. The Latvian food centre on nutritional supplements the registration or refusal of registration may be challenged the Health Ministry within one month from the date of entry into force of the decision. The Ministry of health decision may appeal to the Court.
19. If new information is received or made information re-examination on the basis of which it can be concluded that nutritional supplements that meet the requirements of this regulation which is registered or applied for registration of the Latvian food centre, food supplements can cause hazard to human health, the Latvian food centre has the right to request additional information and the assessment of the competent authorities and to suspend the decision on dietary supplements registration or suspend registration of the product applied for the Latvian food centre for nutritional supplements. On the suspension of that decision the Latvian food centre shall inform Member States, the European Commission and the food and veterinary service. The new decision sends the addressee of the decision within three working days and a question mark in the center of the Latvian food nutritional supplements.
IV. the Labelling of dietary supplements labeled in the order laid down in the legislation on food labelling. The label shall include the following additional indications: 20.1. "food supplement";
20.2. nutrients or substances that characterise the food supplements names or an indication of those nutrients or substances;
20.3. dietary supplements recommended daily intake;
20.4. the quantity of components (nutrients or substances with a nutritional or physiological effect) in units of mass or volume in the daily dose (these rules referred to in annex 1. vitamins and minerals necessary to indicate specific units);
20.5. vitamins and minerals in one packaging unit as a percentage of the recommended daily allowance specified in the legislation on food labelling;
20.6. the recommendation not to use the dietary supplements as a complete and balanced diet substitutes;
UR20.7.br warning that a food supplement should be stored out of the reach of children;
12.9. a warning not to exceed the recommended daily dose.
21. the dietary supplements regulations technical documents, instructions for labelling, presentation and other information, as well as advertising of food supplements should not deploy or use pointers or references that nutritional supplements, treating the condition prevents or cures disease, or references to such a possibility and should not include any direct or indirect reference to the ces that a balanced and varied diet cannot provide sufficient nutrients.
V. concluding questions 22. Be declared unenforceable in the Cabinet of Ministers of 27 April 2004, Regulation No 441 "minimum safety requirements for dietary supplements and their label" (Latvian journal, 2004, nr. 69).
23. Dietary supplements for which the Latvian food centre has issued a positive decision in accordance with the Cabinet of Ministers of 27 April 2004 to establish ments no 441 "minimum safety requirements for dietary supplements and their labelling requirements" and which meets the requirements of this regulation, also be distributed after the entry into force of these regulations.
24. Dietary supplements for which the Latvian food centre has issued a positive decision in accordance with the Cabinet of Ministers of 27 April 2004 the Regulation No. 441 "minimum safety requirements for dietary supplements and their labelling requirements" and used in vitamins and minerals and their compounds, which are not mentioned in annex 1 of these regulations, if these nutritional supplements distributed in the European Union and European economic area Member States before 2002 July 12 , permitted to distribute up to December 31, 2009.
25. Food supplements produced in third countries and on which the Latvian food centre to 2006 January 1 has issued a positive decision, allowed to continue spreading after January 1, 2006, if the Latvian food centre has received this provision, paragraph 12 of the report on compliance with this provision in paragraph 12.2 that the Act or the regulations of the European Union or European economic area Member State competent authorities issued Declaration of conformity assessment who certifies the manufacture of food supplements (including quality control) in compliance with good manufacturing practice.
26. Dietary supplements, which do not comply with the Cabinet of Ministers of 27 April 2004, rule no. 441 "minimum safety requirements in nurture healthcare and nutritional requirements marking" requirements, but the Latvian food centre up to 2 May 2004, has issued a positive opinion and produced or imported for distribution in Latvia until 31 July 2005, allowed to continue to spread, while ending stocks (subject to the expiry date), but not longer than until 1 March 2006.
27. These provisions 12.1. subparagraph shall cease to be in force by 31 December 2006.
28. This provision subparagraph 12.2 shall enter into force on January 1, 2006.
Informative reference to European Union Directive provisions included in the law arising from the European Parliament and of the Council of 10 June 2002 Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements.
Prime Minister a. Halloween Health Minister g. Smith Editorial Note: rules shall enter into force on 24 September 2005.
1. the annex to Cabinet of Ministers of 20 September 2005, the Regulation No 725 vitamins and minerals which may be used in the manufacture of food supplements no PO box
Vitamins and minerals vitamins and minerals use connections 1 2 3 1.
Vitamin a 1.1.
Vitamin a (µ g RE) Retinol, retinyl acetate, retinilpalmitāt, beta-carotene 1.2.
(Μ g) vitamin d cholecalciferol, ergocalciferol 1.3.
Vitamin e (mg α-TE) D-alpha-tocopherol, DL-alpha-tocopherol, D-alpha-tocopheryl acetate, DL-alpha-tocopheryl acetate, D-acid Alpha-tokoferilsukcināt 1.4.
(Μ g) vitamin k PHYLLOQUINONE (phytomenadione) 1.5.
Vitamin B1 (mg) Thiamin chloride, thiamin mononitrate 1.6.
Vitamin B2 (mg) riboflavin, riboflavin sodium phosphate 1.1.
Niacin (mg NE) Nicotinic Acid, NICOTINAMIDE 1.8.
Pantothenic acid (mg) of calcium D-PANTOTHENATE, sodium dexpanthenol D-PANTOTHENATE, 1.9.
Vitamin B6 (mg) Pyridoxine chloride, Pyridoxine phosphate 1.10.
Folic acid (µ g) Pteroilmonoglutamīnskāb-1.11.
Vitamin B12 (µ g), hidroksokobalamīn of cyanocobalamin 1.12.
Biotin (µ g) D-biotin 1.13.
Vitamin c (mg), L-Ascorbic acid sodium L-ascorbate calcium L-ascorbate, potassium L-ascorbate, L-ASCORBYL 6-palmitate 2.
Calcium (mg), calcium carbonate, calcium chloride, calcium salts of citric acid, Calcium Gluconate, calcium glycerophosphate, calcium lactate, calcium salts of orthophosphoric acid, calcium hydroxide, calcium oxide 2.2.
Magnesium (mg) Magnesium acetate, magnesium carbonate, magnesium chloride, magnesium salts of citric acid, magnesium gluconate, magnesium glycerophosphate, magnesium salts of orthophosphoric acid, magnesium lactate, magnesium hydroxide, magnesium oxide, magnesium sulphate 2.3.
Iron (mg) iron (II) carbonate, ferrous citrate, ferric ammonium citrate, ferrous gluconate, iron (II) fumarāt, iron (iii) sodium diphosphate, ferrous lactate, ferrous sulphate, iron (iii) diphosphate (ferric pyrophosphate), iron (iii) saharāt, elemental iron (Carbonyl + electrolytic +-hydrogen reduced) 2.4.
Copper (µ g) copper (II) carbonate, copper citrate, copper gluconate, copper sulphate, copper-lysine complex 2.5.
Iodine (µ g), Sodium iodide, potassium iodate, sodium iodide, potassium iodate 2.6.
Zinc (mg) Zinc acetate, zinc chloride, zinc citrate, zinc gluconate, zinc lactate, zinc oxide, zinc carbonate, zinc sulphate 2.7.
Manganese (mg), Manganese carbonate, manganese chloride, manganese citrate, manganese gluconate, manganese glycerophosphate, manganese sulphate 2.8.
Sodium (mg) of sodium bicarbonate, sodium carbonate, sodium chloride, sodium citrate, sodium gluconate, sodium lactate, sodium hydroxide, sodium salts of orthophosphoric acid 2.9.
Potassium (mg), potassium bicarbonate, potassium carbonate, potassium chloride, potassium citrate, potassium gluconate, potassium glycerophosphate, potassium lactate, potassium hydroxide, potassium salts of orthophosphoric acid 2.10.
Selenium (µ g) sodium selenate, sodium selenite, SODIUM SELENATE 2.11.
Chromium (µ g) chromium (iii) chloride, chromium (iii) sulphate 2.12.
Molybdenum (µ g) ammonium molybdate (molybdenum (VI)), sodium molybdate (molybdenum (VI)) 2.13.
Fluoride (mg) potassium fluoride, sodium fluoride 2.14.
Chloride (mg) 2.15.
Phosphorus (mg) Health Minister g. Smith
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